Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test

NCT ID: NCT04914585

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-12-31

Brief Summary

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CT scans of the spine include vertebrae, intervertebral discs and the spinal cord. These tests are performed in an orderly protocol and allow for three-dimensional reconstruction of the vertebra in sagittal and coronal guides.

Detailed Description

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In spinal surgery, there are a number of navigation technologies based on CT scans performed before surgery (or during surgery) and identify the vertebrae (using special photographs or markers on the spine), such as Mazor with the Renaissance Robotic Surgical System used in hospitals, or BrianLab Which uses non-robotic navigation and is based on a marker located on the patient's back. These technologies are not optimal, and have a number of significant drawbacks: Because during spinal surgery, there is a displacement, the level of accuracy decreases as the surgery progresses. In addition, there is extensive use of radiation in these means since in many cases CT is performed before and during surgery.

Today, in the age of optical detection, it is possible to detect three-dimensional structures in photography and allow high levels of accuracy (less than 0.5 mm). Optical scanning does not include radiation and lasts the entire length of the operation. Of the patient and of the treating staff.

Conditions

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Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord CT Scans

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* men and women
* 18 and above years old
* Patients who have available spinal CT tests will be included in the study
* Patients who are about to undergo spinal surgery

Exclusion Criteria

* NA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deep Health Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josh Schroeder, MD

Role: PRINCIPAL_INVESTIGATOR

Advisor

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ben Metz

Role: CONTACT

+972-546921978

Facility Contacts

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Josh Schroeder, MD

Role: primary

References

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Farah K, Coudert P, Graillon T, Blondel B, Dufour H, Gille O, Fuentes S. Prospective Comparative Study in Spine Surgery Between O-Arm and Airo Systems: Efficacy and Radiation Exposure. World Neurosurg. 2018 Oct;118:e175-e184. doi: 10.1016/j.wneu.2018.06.148. Epub 2018 Jul 3.

Reference Type BACKGROUND
PMID: 30257292 (View on PubMed)

Gebhard F, Weidner A, Liener UC, Stockle U, Arand M. Navigation at the spine. Injury. 2004 Jun;35 Suppl 1:S-A35-45. doi: 10.1016/j.injury.2004.05.009.

Reference Type BACKGROUND
PMID: 15183702 (View on PubMed)

Mendelsohn D, Strelzow J, Dea N, Ford NL, Batke J, Pennington A, Yang K, Ailon T, Boyd M, Dvorak M, Kwon B, Paquette S, Fisher C, Street J. Patient and surgeon radiation exposure during spinal instrumentation using intraoperative computed tomography-based navigation. Spine J. 2016 Mar;16(3):343-54. doi: 10.1016/j.spinee.2015.11.020. Epub 2015 Dec 10.

Reference Type BACKGROUND
PMID: 26686604 (View on PubMed)

Other Identifiers

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0001 (IRB 0485-19)

Identifier Type: -

Identifier Source: org_study_id

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